Actively Recruiting
Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM
Led by i-SENS, Inc. · Updated on 2026-04-09
32
Participants Needed
4
Research Sites
11 weeks
Total Duration
On this page
Sponsors
I
i-SENS, Inc.
Lead Sponsor
I
Integrated Medical Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, single arm, open-label, interventional, pilot study to evaluate the accuracy and precision of the continuous glucose monitoring (CGM) system of i-SENS, Inc., CareSens Air 3, in adult patients with type 1 diabetes.
CONDITIONS
Official Title
Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years, inclusive
- Diagnosed with type 1 diabetes using intensive insulin therapy (multiple daily injections or insulin pump) for at least 3 months
- Willing and able to provide written informed consent to participate in the study
You will not qualify if you...
- Severe skin conditions or alterations at the CGM sensor site, including severe psoriasis, burns, eczema, scars, extensive tattoos, dermatitis herpetiformis, rash, or Staphylococcus aureus infection
- Allergic contact dermatitis to medical adhesives
- History of frequent catheter abscesses related to pump therapy
- Severe hypoglycemia events within 3 months before screening (loss of consciousness or seizures requiring emergency treatment)
- Hypoglycemia unawareness
- Untreated or inadequately treated thyroid or adrenal disease that increases hypoglycemia risk
- Diabetic ketoacidosis within 3 months before screening
- History of epilepsy or syncope within 6 months before screening
- Unstable or insufficiently treated vascular diseases including stroke, transient cerebral ischemia, heart disease, peripheral vascular disease, or serious arrhythmia
- Anemia with hemoglobin below normal range
- Scheduled for X-ray, MRI, CT, or diathermy during the study
- Pregnant, lactating, or planning pregnancy without agreed contraception
- Participation in another study within 2 weeks before screening or plans to join another conflicting study
- Unwillingness to avoid certain foodstuffs as specified
- Cognitive impairment or deemed unsuitable or at increased risk by investigator
- Use of pacemaker or similar medical devices
- HbA1c greater than 9.5%
- Dependency on the sponsor or clinical investigator
- Unwillingness or inability to follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Headlands Research AMCR
Escondido, California, United States, 92025
Not Yet Recruiting
2
Diablo Clinical Research
Walnut Creek, California, United States, 94598
Actively Recruiting
3
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Not Yet Recruiting
4
Rainier Clinical Reseach Center
Renton, Washington, United States, 98057
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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